A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastroesophageal Junction or Gastric Cancer

Status:	Active, not recruiting
Conditions:	Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	1/16/2019
Start Date:	June 10, 2013
End Date:	October 6, 2021

A Double-blind, Placebo-controlled, Randomized, Multicenter Phase III Study Evaluating the Efficacy and Safety of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-positive Metastatic Gastroesophageal Junction and Gastric Cancer

This double-blind, placebo-controlled, randomized, multicenter, international, parallel arm
study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab,
fluoropyrimidine and cisplatin as first-line treatment in participants with HER2-positive
metastatic gastroesophageal junction (GEJ) or gastric cancer (GC). Participants will be
randomized to receive pertuzumab 840 milligrams (mg) or placebo intravenously every 3 weeks
(q3w) in combination with trastuzumab (initial dose of 8 milligrams per kilogram [mg/kg]
intravenously [IV] followed by 6 mg/kg IV q3w) and cisplatin and fluoropyrimidine
(capecitabine or 5-fluorouracil) for the first 6 treatment cycles. Participants will continue
to receive pertuzumab or placebo and trastuzumab until disease progression occurrence of
unacceptable toxicity or withdrawal from the study for another reason.

Inclusion Criteria:

- Histologically confirmed metastatic adenocarcinoma of the stomach or GEJ

- Measurable or evaluable non-measurable disease as assessed by the investigator
according to RECIST v1.1 criteria

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Life expectancy greater than equal to (>/=) 3 months

Exclusion Criteria:

- Previous cytotoxic chemotherapy for advanced (metastatic) disease

- Evidence of disease progression documented within 6 months after completion of prior
neoadjuvant or adjuvant cytotoxic chemotherapy, or both, or radiotherapy for GEJ
adenocarcinoma

- Previous treatment with any HER2-directed therapy, at any time, for any duration

- Previous exposure to any investigational treatment within 30 days before the first
dose of study treatment

- Radiotherapy within 30 days before the first dose of study treatment (within 2 weeks
if given as palliation to bone metastases, if recovered from all toxicities)

- History or evidence of brain metastases

- Clinically significant active gastrointestinal (GI) bleeding (Grade >/=2 according to
National Cancer Institute [NIC]-Common Terminology Criteria for Adverse Events Version
4.0 [CTCAEv.4.0])

- Residual toxicity resulting from previous therapy (for example, hematologic,
cardiovascular, or neurologic toxicity that is Grade >/=2). Alopecia is permitted

- Other malignancy (in addition to gastric cancer [GC]) within 5 years before
enrollment, except for carcinoma in situ of the cervix or squamous or basal cell
carcinoma of the skin that has been previously treated with curative intent

- Inadequate hematologic, renal or liver function

- Pregnant or lactating women

- History of congestive heart failure of any New York Heart Association (NYHA) criteria

- Angina pectoris requiring treatment

- Myocardial infarction within the past 6 months before the first dose of study drug

- Clinically significant valvular heart disease or uncontrollable high-risk cardiac
arrhythmia

- History or evidence of poorly controlled hypertension

- Baseline left ventricular ejection fraction (LVEF) value less than (<) 55 percent (%)

- Any significant uncontrolled intercurrent systemic illness

- Positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection

We found this trial at

sites

Weill Medical College of Cornell University; Division of Hematology & Medical Oncology

New York, New York 10065

from

New York, NY